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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The study was initiated on August 8, 2006. Primary endpoint (Survival) was evaluated on February 7, 2011 and again at completion of follow-up period, October 13, 2013. Participants with a histologic diagnosis of untreated, measurable, and unresectable Stage III or Stage IV malignant melanoma were eligible.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Of 681 patients enrolled, 502 were randomized, and 498 received treatment. Reasons for not starting treatment: 147 no longer met study criteria (including 3 who were randomized but did not receive treatment), 25 withdrew consent, 3 died, 2 had adverse events, 2 lost to follow-up, 2 poor compliance or noncompliance, 1 not reported, and 1 other.

In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase.

Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase.

Participant Flow for 4 periods

Period 1: Enrolled and Randomized

Ipilimumab and Dacarbazine

Placebo and Dacarbazine

STARTED

250

252

COMPLETED

247 [1]

251 [2]

NOT COMPLETED

3

1

No longer met study criteria

3

0

Lost to Follow-up

0

1

[1]

3 randomized but who did not receive treatment (no longer met study criteria).

[2]

1 randomized but who did not receive treatment (lost to follow-up).

Period 2: Received Treatment in Induction Phase

Ipilimumab and Dacarbazine

Placebo and Dacarbazine

STARTED

247

251

COMPLETED

45 [1]

54 [2]

NOT COMPLETED

202

197

Disease Progression

88

152

Study Drug Toxicity

83

10

Death

8

15

Deterioration/Undocumented Progression

9

8

Adverse Event

6

7

Withdrawal by Subject

6

5

Physician Decision

2

0

[1]

45 participants on treatment at end of Induction Phase. Study undergoing closure.

[2]

54 participants on treatment at end of Induction Phase. Study undergoing closure.

Period 3: Received Treatment in Maintenance Phase

Ipilimumab and Dacarbazine

Placebo and Dacarbazine

STARTED

43 [1]

53 [2]

COMPLETED

11 [3]

6 [4]

NOT COMPLETED

32

47

Disease Progression

26

41

Study Drug Toxicity

4

0

Withdrawal by Subject

1

3

Adverse Event

0

3

Deterioration/Undocumented Progression

1

0

[1]

2 completed Induction Phase but did not enter Maintenance Phase

[2]

1 completed Induction Phase but did not enter Maintenance Phase

[3]

Study is in closure at this time. 11 in Maintenance Phase not yet summarized.

[4]

Study is in closure. 6 participants in Maintenance Phase not yet summarized.

Period 4: Follow-up Phase

Ipilimumab and Dacarbazine

Placebo and Dacarbazine

STARTED

247 [1]

251 [1]

COMPLETED

236

245

NOT COMPLETED

11

6

On-going participants still on drug

11

6

[1]

All participants received study drug. Follow-up was performed for those leaving earlier phases.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years) ]

Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved [ Time Frame: Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years) ]

In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 wks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase.

Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.